Neurophysiologic Biomarkers in Rett Syndrome

Part of paid clinical trials in Los Angeles, California.

Sponsor
Children's Hospital of Philadelphia
Study ID
NCT05932589
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
FEMALE
Age
1 Year - 18 Years
Healthy Volunteers
Accepted

Interventions

  • EEG and Auditory and Visual Evoked Potentials (AEP and VEP) — OTHER
    Through up to eight standardized sessions, participants will undergo AEP and VEP, as well as resting state EEG.
  • Clinical assessment — OTHER
    Established clinical measures for RTT will be collected for RTT participants

Study Details

The goal of this observational study is to identify candidate biomarkers in individuals with Rett Syndrome (RTT). The main questions it aims to answer are: * Do these biomarkers change during clinical changes in individuals with RTT? * Are biomarkers stable over time in clinically stable individuals? * Do these biomarkers correlate with severity of RTT? Participants will be asked to undergo an electroencephalogram (EEG) with measurements of Evoked Potentials (EP) to measure electrical activity in the brain. Researchers will compare findings in individuals with RTT to those in typically developing individuals to see if there are differences between the two groups.

Key Dates

Start date
Oct 11, 2023
Status verified
Oct 2025
Primary completion
Mar 31, 2028
Completion
Mar 31, 2029

Study Design

Enrollment
202 participants (estimated)

Arms

  • Arm: RTT Females
    Females with Rett Syndrome
  • Arm: Controls
    Females with typical development

Primary Outcome Measure

Auditory Evoked Potential (AEP) latency (ms) [ Time Frame: 5 years ]

Central Contacts

Locations (6)

FacilityCityStateZIPSite coordinators
Children's Hospital of Los AngelesLos AngelesCalifornia90027
Shefali Spurling Jeste, MD (PRINCIPAL_INVESTIGATOR)
Payal Kenia Gu, MD (SUB_INVESTIGATOR)
Children's Hospital ColoradoAuroraColorado80045
Timothy Benke, MD, PhD (PRINCIPAL_INVESTIGATOR)
Boston Children's HospitalBrooklineMassachusetts02445
April Levin, MD (PRINCIPAL_INVESTIGATOR)
David Lieberman, MD, PhD (SUB_INVESTIGATOR)
Children's Hospital of PhiladelphiaPhiladelphiaPennsylvania19104
Holly Dubbs, MS, CGC
[email protected]
215-590-1719
Eric Marsh, MD, PhD (PRINCIPAL_INVESTIGATOR)
Vanderbilt University Medical CenterNashvilleTennessee37232
Nicole Thompson
[email protected]
615-343-4586
Jeffrey Neul, MD, PhD (PRINCIPAL_INVESTIGATOR)
Texas Children's HospitalHoustonTexas77030
Bernhard Suter, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Los Angeles, CA

By research site
Children's Hospital of Los Angeles· Los Angeles, CAChildren's Hospital Colorado· Aurora, COBoston Children's Hospital· Brookline, MAChildren's Hospital of Philadelphia· Philadelphia, PAVanderbilt University Medical Center· Nashville, TNTexas Children's Hospital· Houston, TX

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